PMID- 27681863
OWN - NLM
STAT- MEDLINE
DCOM- 20171226
LR  - 20220330
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Print)
IS  - 0923-7534 (Linking)
VI  - 27
IP  - 12
DP  - 2016 Dec
TI  - Validation of the German patient-reported outcomes version of the common 
      terminology criteria for adverse events (PRO-CTCAE).
PG  - 2294-2299
LID - 10.1093/annonc/mdw422 [doi]
AB  - BACKGROUND: Integrating the patient's perspective has become an increasingly 
      important component of adverse event reporting. The National Cancer Institute has 
      developed a Patient-Reported Outcomes version of the Common Terminology Criteria 
      for Adverse Events (PRO-CTCAE). This instrument has been translated into German 
      and linguistically validated; however, its quantitative measurement properties 
      have not been evaluated. PATIENTS AND METHODS: A German language survey that 
      included 31 PRO-CTCAE items, as well as the EORTC QLQ-C30 and the Oral Mucositis 
      Daily Questionnaire (OMDQ), was distributed at 10 cancer treatment settings in 
      Germany and Austria. Item quality was assessed by analysis of acceptability and 
      comprehensibility. Reliability was evaluated by using Cronbach's' alpha and 
      validity by principal components analysis (PCA), multitrait-multimethod matrix 
      (MTMM) and known groups validity techniques. RESULTS: Of 660 surveys distributed 
      to the study centres, 271 were returned (return rate 41%), and data from 262 were 
      available for analysis. Participants' median age was 59.7 years, and 69.5% of the 
      patients were female. Analysis of item quality supported the comprehensibility of 
      the 31 PRO-CTCAE items. Reliability was very good; Cronbach's' alpha correlation 
      coefficients were >0.9 for almost all item clusters. Construct validity of the 
      PRO-CTCAE core item set was shown by identifying 10 conceptually meaningful item 
      clusters via PCA. Moreover, construct validity was confirmed by the MTMM: 
      monotrait-heteromethod comparison showed 100% high correlation, whereas 
      heterotrait-monomethod comparison indicated 0% high correlation. Known groups 
      validity was supported; PRO-CTCAE scores were significantly lower for those with 
      impaired versus preserved health-related quality of life. CONCLUSION: A set of 31 
      items drawn from the German PRO-CTCAE item library demonstrated favourable 
      measurement properties. These findings add to the body of evidence that PRO-CTCAE 
      provides a rigorous method to capture patient self-reports of symptomatic 
      toxicity for use in cancer clinical trials.
CI  - (c) The Author 2016. Published by Oxford University Press on behalf of the European 
      Society for Medical Oncology. All rights reserved. For permissions, please email: 
      journals.permissions@oup.com.
FAU - Hagelstein, V
AU  - Hagelstein V
AD  - Institute of Pharmacy, Clinical Pharmacy, University of Bonn, Bonn, Germany.
FAU - Ortland, I
AU  - Ortland I
AD  - Institute of Pharmacy, Clinical Pharmacy, University of Bonn, Bonn, Germany.
FAU - Wilmer, A
AU  - Wilmer A
AD  - Institute of Pharmacy, Clinical Pharmacy, University of Bonn, Bonn, Germany.
FAU - Mitchell, S A
AU  - Mitchell SA
AD  - Division of Cancer Control and Population Sciences, Outcomes Research Branch, 
      National Cancer Institute, Rockville, USA.
FAU - Jaehde, U
AU  - Jaehde U
AD  - Institute of Pharmacy, Clinical Pharmacy, University of Bonn, Bonn, Germany 
      u.jaehde@uni-bonn.de.
LA  - eng
PT  - Journal Article
DEP - 20160928
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - Antineoplastic Agents/*adverse effects/therapeutic use
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/pathology
MH  - Female
MH  - Germany
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasms/drug therapy/*epidemiology
MH  - *Patient Outcome Assessment
MH  - Quality of Life
MH  - Surveys and Questionnaires
PMC - PMC6267864
OTO - NOTNLM
OT  - German
OT  - PRO-CTCAE
OT  - cancer
OT  - patient-reported outcomes
OT  - questionnaire
OT  - validation
EDAT- 2016/09/30 06:00
MHDA- 2017/12/27 06:00
PMCR- 2017/12/01
CRDT- 2016/09/30 06:00
PHST- 2016/04/10 00:00 [received]
PHST- 2016/07/30 00:00 [revised]
PHST- 2016/08/29 00:00 [accepted]
PHST- 2016/09/30 06:00 [pubmed]
PHST- 2017/12/27 06:00 [medline]
PHST- 2016/09/30 06:00 [entrez]
PHST- 2017/12/01 00:00 [pmc-release]
AID - S0923-7534(19)36545-7 [pii]
AID - mdw422 [pii]
AID - 10.1093/annonc/mdw422 [doi]
PST - ppublish
SO  - Ann Oncol. 2016 Dec;27(12):2294-2299. doi: 10.1093/annonc/mdw422. Epub 2016 Sep 
      28.